Cephalon Receives FDA Approval for TREANDA, a Novel Chemotherapy for Chronic Lymphocyti...(ulticenter open-label pivotal studyof 30...)

Date:3/20/2008

ulticenter, open-label pivotal study of 301 treatment-naive patients with CLL, those who received TREANDA had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved chemotherapy for patients with CLL. Specifically, TREANDA patients had a significantly higher overall response (59 percent of patients responded to TREANDA and 26 percent of patients responded to chlorambucil; p < 0.0001). Patients who received TREANDA also had a higher complete response rate than those treated with chlorambucil (8 percent vs. <1 percent), which means that after treatment with TREANDA, some patients had no signs of disease in their blood.

Importantly, TREANDA patients also had a significantly longer progression- free survival (18 months vs. 6 months; Hazard Ratio = 0.27; p < 0.0001), meaning the disease did not get worse for a significant period of time. The response to TREANDA lasted longer (duration of response) than in patients who received chlorambucil (19 months vs. 7 months). The most common adverse events in the trial were myelosuppression, fever, nausea, and vomiting.

TREANDA has been granted orphan drug status by the FDA for the treatment of CLL. The orphan drug designation will provide marketing exclusivity in this indication until March 2015.

About TREANDA

TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.

In December 2007, Cephalon submitted an NDA requesting approval of TREANDA for the treatment of patients with indolent (slow-growing) non-Hodgkin's ly
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SOURCE Cephalon, Inc. Copyright©2008 PR Newswire. All rights reserved

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